Request for Information (RFI) on the Development of a Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System

Replace text above with title of notice.

Notice Number:

NOT-NS-12-017

Key Dates

Release Date:

Response Date: June 30, 2012

Release Date is generally provided by OER, but can be provided by IC for a special date (default is to leave blank).

Related Notices

NOT-NS-12-016

Replace “None” with any related notices. Please include only Announcements from the NIH Guide; do not include websites, FAQs, or other material.

Issued by

Delete from the following list so that you are left with relevant IC. Do not include NIH (top line) unless you are issuing from the OD. If you are not part of NIH, please insert full name and abbreviation in manner shown below.

National Institute of Neurological Disorders and Stroke (NINDS)

Center for Information Technology (CIT)

Purpose

Replace text below as appropriate for your Notice. To facilitate conversion to HTML, text formatting in this document is limited. To apply formatting, highlight the text and apply the style (described below).

LOOK IN THE “STYLES” SECTION OF YOUR “HOME” RIBBON IN MICROSOFT WORD TO FIND THE STYLES LISTED BELOW.

StrongBolded text

Emphasis Italics text

Strong EmphasisBoth bold and italics text – please use this as a substitution for underlined text which should be avoided in web pages because users confuse underlined text with hyperlinks.

List ParagraphIndented text

BulletBulleted and indented text

Double Indent BulletUse for bullets when the section is already indented once (e.g. bullets under a List Paragraph)

Heading 4Use for headings of any elements/fields you add to the FOA

Heading 4 IndentIndented version of Heading 4 (aligns with List Paragraph)

TitleUse only for the title and number of the FOA

NormalUse for all text, except as described above.

If you apply a style and you later want to remove the style, highlight the text and apply the normal style.

If clicking the normal style does not remove all formatting, press the two keys, Ctrl and Spacebar, at the same time while text is highlighted.

To promote a uniform format for all Notices, only the “Purpose” and “Inquiries” headings use Heading 3 style. If the IC wishes to add additional headings, the Heading 4 style is available

As stated in the recent Notice (NOT-NS-12-016), the NIH, in collaboration with the Department of Defense, is developing the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System to further accelerate the pace of discovery and advance research. The FITBIR informatics system will provide the traumatic brain injury (TBI) research community with a common platform for exchanging data, protocols, and research-related information.

The goal of this RFI is to seek public comment on considerations in the development and implementation of the FITBIR informatics system. Information obtained via this RFI will help to improve the design and policies of the FITBIR informatics system to optimize its utility, productivity, and overall value to the scientific research community and the public health.

Background

TBI is a major medical problem that lacks sensitive, predictive diagnostic tools and proven effective treatments. Developing effective diagnostics and treatments is challenging because of the heterogeneity of TBI, which spans all ages, evolves over time, and includes a wide variety of causes and injury severities. To address these challenges, the FITBIR informatics system aims to provide high quality, highly granular and contemporary data that can be accessed and analyzed by scientific experts. The FITBIR informatics system will enable central archiving of data from both prospective and retrospective studies, and thereby prevent the data sets from being lost to off-line, long-term storage in a multitude of distributed databases and institutions. A large, rich clinical data set that is stored in a secure, centralized database has the potential to address critical questions and fundamental needs in TBI diagnosis and treatment.

Functionality will include storage, query, retrieval, off-site backup, and optionally pre-processing, post-processing, and collaboration between approved researchers and federal agencies. Sharing of phenotypic, imaging, functional outcome, pathology, and genomic data from a central secure repository will greatly accelerate the ability for researchers to: (a) validate research results; (b) pool standardized information to improve statistical significance; (c) analyze data collected by others to explore new hypotheses as well as the variability in different treatment protocols, in an effort to improve TBI treatments for all; and d) use sophisticated analysis tools to gain a better understanding of risk and mitigating factors in outcome after TBI.

Expectations Defined in the Policy for Investigators

The detailed expectations are enumerated in the individual sections of this policy, and summarized as follows:

Investigators submitting FITBIR data are expected to:

Provide descriptive information about their studies;

Submit coded genotypic and phenotypic data to the FITBIR Informatics System; and

Submit a data submission form, providing assurance that all data are submitted to the DOD and the NIH in accord with applicable laws and regulations, and that the identities of research participants will not be disclosed to the FITBIR Informatics System.

Investigators requesting and receiving FITBIR data are expected to:

Submit a description of the proposed research project;

Submit a data access request

Protect data confidentiality;

Ensure that data security measures are in place;

Notify the Data Access and Quality Committee of policy violations; and

Submit annual progress reports detailing significant research findings.

Information Requested

This RFI invites input from potential FITBIR users as well as the broader biomedical research community and other interested parties on the following and other matters relating to the FITBIR Informatics System:

1. FITBIR Data Sharing Policies, including timelines for uploading and sharing data, and requirements for accessing data.

2. Strategies and incentives for promoting collaboration and use of the FITBIR Informatics System.

3. Issues regarding informed consent and re-consent for data sharing.

4. Research priorities for the FITBIR Informatics System.

5. Strategies and tools for increasing the availability of aggregate data and publications to the broad TBI community, e.g. patients and families, healthcare providers, policy makers, and other stakeholders.

Responses

Responses are due by June 30, 2012 and may be directed to:

FITBIR Operations Team

Email:

Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Proprietary, classified, confidential, or sensitive information should not be included in your response. Replies to individual topics are optional, and requests for anonymous responses will be honored. The information provided will be analyzed and may appear in various reports.

This Request for Information (RFI) is for planning purposes only and is not a solicitation for applications or an obligation on the part of the United States (U.S.) Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any comment submitted or for its use of that comment.

Inquiries

Include the name and contact information of the program contact you list in the ENS record

For further information contact:

FITBIR Operations Team

Email:

Notice - General Template January 30, 2012 1